APOMINE Intermittent apomorphine hydrochloride hemihydrate 30mg/3mL injection cartridge, Interpharma Pty Ltd, CON-1235
Product name
APOMINE Intermittent apomorphine hydrochloride hemihydrate 30mg/3mL injection cartridge
Sponsor name
Interpharma Pty Ltd
ARTG
Consent start
Consent no.
CON-1235
Standard
Paragraph 8(1)(a), Paragraph 8(1)(o), Subsection 9(3), Subparagraph 10(3)(a)(i), Subsection 11(5), Paragraph 10(4)(c), Paragraph 10(4)(j), Subsection 11 (1) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products: ' Contain the name of the UK labelled product Dacepton 10 mg/ml on
3 sides of the carton other than the main label. ' The Correct name of the
medicine is not on 3 opposing sides of the carton. ' The name of the medicine
and the active ingredients are not presented as a cohesive unit on the main
label. ' The quantity of all excipients is not provided on the carton. ' The
storage conditions are expressed as 'Do not store above 25° C.' which is not an
approved storage statement. ' The name on the vial is not the Australian
registered name. ' The name of the sponsor and distributor on the vial does not
match the registered details. ' All labels have the incorrect expression of the
quantity of the active ingredient.
Conditions imposed
1. A 'Dear Healthcare Provider' and 'Dear Pharmacist' letter identical to that
provided to the TGA on 1 May 2024 will be supplied with each affected batch
describing the differences in the presentation of the medicine and referencing
the Australian Product Information (PI) which will be supplied with each batch.
2. All over-stickering as described in the email dated 1 May 2024 including the
Signal Headings as per the Poison Standard, the number and reference to
the Australian PI.
3. A 'Dear Patient' letter identical to that provided to the TGA on 1 May 2024
will be supplied with each affected batch describing the differences in the
presentation of the medicine and referring to the correct contact details for
any concerns. This letter will also refer patients to the Australian PI supplied
with the product but not in the carton.
Therapeutic product type
Prescription medicines